Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003, AMD. 1:2005, IDT)
This Malaysian Standard specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to MS ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
This standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
This standard is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
This standard is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO MS ISO 14630 for excluded products.
This standard is not ap
Published
• (none) / (none) / (none)
PDF
02/05/2019
99
NSC 18 - Medical Devices and Facilities for Healthcare
